About Us:

PreCert is a company dedicated to helping medical device businesses meet and exceed regulatory requirements. Comprising a team of experienced specialists, we provide flexible and customized solutions to ensure successful certification and regulatory compliance. Our passion lies in working as an integral part of our clients' teams to achieve shared goals.

Commitment to Quality

At PreCert, quality is a cornerstone of everything we do. Our services are meticulously designed to ensure that our clients not only meet but surpass the highest quality standards in their processes and products. By implementing effective quality management systems and conducting regular detailed audits, we guarantee comprehensive regulatory compliance. This relentless focus on quality ensures that every aspect of our service aligns with industry best practices and contributes to the enhanced reliability and safety of our clients’ products.

Our Mission

Our mission is to serve as a reliable and long-term partner in the regulatory landscape of medical technology. We are committed to providing effective and cost-efficient solutions tailored to meet the unique needs of our clients, helping them achieve their objectives. By leveraging our deep industry knowledge and regulatory expertise, we aim to simplify the complexities of compliance and certification, allowing our clients to focus on innovation and market expansion.

Global Reach and International Expertise

In addition to our commitment to quality and client-focused solutions, PreCert boasts a global reach, offering our expertise across international markets. Our extensive experience with multinational regulatory frameworks enables us to provide tailored guidance no matter where your business is located. Whether navigating the FDA’s regulations in the United States, the MDR in Europe, or other international standards, we have the strategic insights and practical experience to ensure your products achieve global compliance. This international perspective not only enhances your ability to operate in diverse markets but also provides a competitive edge by aligning your medical devices with global quality and safety standards. We bridge local and international requirements, facilitating seamless market entry and expansive growth opportunities worldwide.